This specification covers the identification of: drug contained in the prefilled syringe or delivery sysetm and the concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration. The label copy shall comply with the specified requirements. Delivery systems shall not resemble a normal syringe and shall be unsuitable for direct intravenous line injection. The copy for the proprietary name or established name of the drug shall be legible in accordance with the legibility test.

1.1 This specification covers the identification of:

1.1.1 The drug contained in the prefilled syringe or delivery system.

1.1.2 The concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration.